Publications

Publications

Just One More Day Compliance Deadline for New ClinicalTrials gov Regulations is Tuesday April 18 2017

On 21 September 2016, the Department of Health and Human Services (HHS) published a final rule that clarified and expanded the requirements for clinical trial registration and results...

Hogan Lovells Publications

Ready, Set... Cures Act Expanded Across Policy Deadline Is Almost a Go

As we have mentioned in a previous article, the 21st Century Cures Act (enacted December 13, 2016) gave companies 60 calendar days to make their expanded access policies for certain...

Hogan Lovells Publications

A "Cure" for Combination Products: 21st Century Cures Act Mandates Greater Transparency of Combination Product Designations

The 21st Century Cures Act ushers in significant changes to the regulatory review of drug/biologic/device combination products. The regulation of combination products has been somewhat...

Hogan Lovells Publications

In The Midnight Hour: FDA Issues 2 Draft Guidances and a First Amendment Memorandum on the Cusp of a New Administration

Over the past few days, FDA issued three documents related to the scope of permissible communications by drug and device companies to various parties. We believe FDA aimed to accomplish two ...

Hogan Lovells Publications

Short-fuse compliance deadline for expanded access provision in 21st Century Cures Act

Under Section 3032 of the 21st Century Cures Act, manufacturers and distributors of investigational drugs for serious diseases or conditions have 60 calendar days after the date of...

Hogan Lovells Publications

Much to metabolize: The 21st Century Cures Act introduces numerous changes to FDA’s drug regulatory framework to spur development of new treatments

The 21st Century Cures Act (Cures Act) has become law with measures designed to deliver new cures and treatments to patients.  Among these measures are a broad range of changes to the...

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